Problems in the regulatory policy of the drug market

OBJECTIVE Analyze the implementation of drug price regulation policy by the Drug Market Regulation Chamber.METHODS This is an interview-based study, which was undertaken in 2012, using semi-structured questionnaires with social actors from the pharmaceutical market, the pharmaceuticals industry, consumers and the regulatory agency. In addition, drug prices were compiled based on surveys conducted in the state of Sao Paulo, at the point of sale, between February 2009 and May 2012.RESULTS The mean drug prices charged at the point of sale (pharmacies) were well below the maximum price to the consumer, compared with many drugs sold in Brazil. Between 2009 and 2012, 44 of the 129 prices, corresponding to 99 drugs listed in the database of compiled prices, showed a variation of more than 20.0% in the mean prices at the point of sale and the maximum price to the consumer. In addition, many laboratories have refused to apply the price adequacy coefficient in their sales to government agencies.CONCLUSIONS The regulation implemented by the pharmaceutical market regulator was unable to significantly control prices of marketed drugs, without succeeding to push them to levels lower than those determined by the pharmaceutical industry and failing, therefore, in its objective to promote pharmaceutical support for the public. It is necessary reconstruct the regulatory law to allow market prices to be reduced by the regulator as well as institutional strengthen this government body.

Performance Septic Systems: Does an Advanced Septic System Provide Adequate Treatment on Black Hammock Island and is there Adequate Regulatory Policy to Ensure Integrity?

This project determined if the performance based septic system, proposed for a development on Black Hammock Island in Jacksonville, Florida, is the best choice to prevent environmental contamination from septic tanks and if adequate regulatory policy exists. Research shows a central wastewater treatment plant provides the most efficient pollutant removal but can be cost prohibitive. This project found performance based systems surpasses conventional septic system performance and are more suited and economical to remote areas without sewer service. This project finds current regulations to be inadequate and supports ordinance changes proposed by the Mayor of Jacksonville to enhance the current policy and provide more adequate and meaningful regulation.

The many uses of regulatory impact assessment: A meta-analysis of EU and UK cases

Research on regulation has crossed paths with the literature on policy instruments, showing that regulatory policy instruments contain cognitive and normative beliefs about policy. Thus, their usage stacks the deck in favor of one type of actor or one type of regulatory solution. In this article, we challenge the assumption that there is a predetermined relationship between ideas, regulatory policy instruments, and outcomes. We argue that different combinations of conditions lead to different outcomes, depending on how actors use the instrument. Empirically, we analyze 31 EU and UK case studies of regulatory impact assessment (RIA) - a regulatory policy instrument that has been pivotal in the so-called better regulation movement. We distinguish four main usages of RIA, that is, political, instrumental, communicative, and perfunctory. We find that in our sample instrumental usage is not so rare and that the contrast between communicative and political usages is less stark than is commonly thought. In terms of policy recommendations, our analysis suggests that there may be different paths to desirable outcomes. Policymakers should therefore explore different combinations of conditions leading to the usages they deem desirable rather than arguing for a fixed menu of variables.

Brazil's new national policy on solid waste: challenges and opportunities

Brazil, one of the world's largest developing countries, has recently introduced a new solid waste management regulatory policy. This new regulatory policy will have implications for a wide variety of stakeholders and sets the stage for opportunities and lessons to be learned. These issues are discussed in this article. © 2013 Springer-Verlag Berlin Heidelberg.

New directions in telecommunications policy /

Includes bibliographies and indexes.

Pressure groups and experts in environmental regulation

We study a problem of adverse selection in the context of environmental regulation, where the firm may suffer from a certain degree of ignorance about its own type. In a framework like the construction of a certain infrastructure project, the presence of ignorance about its impact on the environment, can play an important role in the determination of the regulatory policy. First, an optimal contract is constructed for any exogenous level of ignorance. Second, the presence of potentially informed third-parties is studied from the perspective of the regulator, which allows us to analyze the impact on the efficiency of the contract, of the presence of environmentalists and of experts. Then, we obtain some insights on how the problem differs when the degree of ignorance is a choice variable for the firm. We finally use our results to derive policy implications concerning the existing envoronmental regulation, and the potential role of interested parties as information providers.

The Formal Independence of Regulators: A Comparison of 17 Countries and 7 Sectors

This article seeks to explain the pattern of delegation to independent regulatory agencies in Western Europe. Two types of arguments are advanced to explain variations in the formal independence of regulators. Firstly, the need for governments to increase their credible commitment capacity may lead them to delegate regulation to an agency that is partly beyond their direct control. Secondly, delegation may be a response to the political uncertainty problem, which arises when governments are afraid of being replaced by another coalition with different preferences, which could decide to change existing policy choices. In addition, veto players may constitute a functional equivalent of delegation, since they influence policy stability and therefore tend to mitigate both the credibility and the political uncertainty problems. These arguments are consistent with the results of the empirical analysis of the formal independence of regulators in seventeen countries and seven sectors.

Judiciário e política regulatória: instituições e preferências sob a ótica dos custos de transação

Judiciary and regulatory policy. Increasingly, judges and the courts appear as actors capable of affecting the trajectory of the government decisions, as strategic agents in the policy process. This paper presents an analytical model able to clearly and objectively measure the impact of judicial review in the design of policies in the sphere of economic regulation. Underlying the model is the concept of transaction costs, through which one can raise the levels of intervention of the judiciary in regulatory policy. In addition to the analytical model, the article demonstrates that the interaction between the heterogeneity of preferences in the courts and institutional mechanisms of the justice system is capable of generating greater coordination and cooperation than expected.

Le jeune téléspectateur, objet de discours social : le cas du Chili «post-1990»

Cette thèse s’interroge sur le phénomène du jeune téléspectateur contemporain. Je questionne cette « réalité », qui fait l’objet de discours et de pratiques sociales au quotidien. L’idée de l’existence « objective » de l’enfant téléspectateur depuis l’avènement de la télévision est si fertile, qu’elle a même contribué au développement d’un sous-domaine de recherche en communication : la communication jeunesse. J’inclus également ce sous-domaine dans la problématique. Ce faisant, je tente d’esquisser une théorisation de l’enfant téléspectateur, en le comprenant comme une formation discursive et sociale. Suivant le point de vue de l’analyse de discours de Michel Foucault (1969), j’axe son étude en articulant deux éléments qui forment les objets sociaux : le régime de vérité et les formations discursives. Ainsi, je réfléchis au jeune téléspectateur comme objet de savoir et de vérité, et comme fruit d’un ensemble de formations discursives. J’ancre empiriquement le questionnement du jeune téléspectateur contemporain dans le Chili « post-1990 ». Je propose une approche méthodologique et analytique me permettant de rendre compte de l’articulation d’éléments hétérogènes qui participent au façonnement discursif et social de celui-ci. Cet outil exploratoire est « le rhizome », que j’emprunte à Gilles Deleuze et à Félix Guattari (1976). Le rhizome m’est utile pour rendre compte des multiples portes d’entrée dans la formation discursive de l’enfant téléspectateur, du déplacement comme chercheuse à l’intérieur de celle-ci, et des figures qui se forment par l’articulation du discours et des pratiques entreprises à son égard. Ce faisant, je propose une archive d’époque de l’enfant téléspectateur du Chili « post-1990 ». Dans celle-ci, je montre des modalités particulières de sa formation discursive et des figures hétéroclites de celui-ci qui ont émergé dans les analyses. Finalement, je présente un ensemble de pratiques discursives qui ont également fait surface dans les analyses. Ces pratiques emploient la figure de l’enfant téléspectateur pour instaurer discursivement d’autres « réalités », qui ne le concernent pas directement. M’appuyant sur Jean-Michel Berthelot (1992), notamment sur son concept d’« opérateur discursif », je qualifie ainsi ces pratiques observées.

The cyclical behavior of bank capital buffers in an emerging economy: size do matters

Using a panel of Colombian banks and quarterly data between 1996:1 and 2010:3, we study the relationship between short-run adjustemnts in bank capital buffers and the business cycle. We follow a partial adjustment framework and control for several variables that have been identified as important determinants of bank capital buffers in previous studies, and find that bank capital buffers vary over the business cycle. We are able to identify a negative co-movement of capital buffers and and the business cycle. However, we also find that capital buffers of small and large banks behave asymmetrically during the business cycle. While the former appear to be constant over time, once the appropriate set of control variables is used, the latter present a countercyclical behavior. Our results suggest the possible need of the implementation of regulatory policy measures in developing countries

Performance and efficiency in Colombia's power utilities: an assessment of the 1994 reform

El artículo describe las características centrales de la reforma regulatoria al sector eléctrico en 1994 y evalúa el desempeño y la eficiencia de las empresas públicas antes y después de la reforma. El análisis de desempeño evalúa los cambios en medias y medianas en ganancias, eficiencia, inversión y ventas de las empresas privatizadas en el sector. La eficiencia técnica es estimada mediante la técnica DEA en una muestra de 33 plantas térmicas de energía, que representan el 85% del parque térmico; y 12 empresas distribuidoras de energía. La muestra de plantas generadoras está compuesta por plantas que estaban activas antes de la reforma y plantas nuevas que entraron en operación después de la reforma. Los principales resultados muestran que la eficiencia mejoro después de la reforma y que la política regulatoria ha tenido un efecto positivo en la eficiencia de la generación térmica de energía. Por el contrario, las distribuidoras de energía menos eficientes empeoraron después de la reforma y no llevaron a cabo una reestructuración para alcanzar la eficiencia productiva respecto a las empresas que conforman la frontera de eficiencia en distribución de energía.

Privatization in Colombia: a plant performance analysis

El artículo describe el programa de privatización en el sector real de la economía Colombiana durante los años noventa y ubica esta política en un contexto de desregulación de mercados y promoción de la inversión privada en la oferta de infraestructura publica y servicios públicos domiciliarios. El articulo evalúa el programa de privatización en los sectores manufacturero y de generación de energía eléctrica. Se hacen mediciones ex - post y análisis econométrico del desempeño de las firmas privatizadas. En el sector manufacturero la muestra analizada esta compuesta por 30 firmas manufactureras de gran tamaño, donde el Instituto de Fomento Industrial era socio fundador. Los principales resultados sugieren que estas firmas mantuvieron un comportamiento pro - cíclico relativo a su principal competidor privado y desestimaron planes drásticos de reestructuración operativa. Para el grupo de firmas de generación de energía el articulo estudia el impacto de la reforma regulatoria en el proceso de entrada al mercado, estructura de propiedad, competencia de mercado y eficiencia productiva. La medición de eficiencia productiva usa la técnica de Data Envelope Análisis para 33 plantas que representan el 85% de la capacidad instalada en la generación térmica de energía eléctrica. La muestra esta compuesta por plantas que estaban en funcionamiento antes de la reforma y las entrantes que comenzaron su operación comercial después de la reforma. Los resultados sugieren que los niveles de evidencia en la generación térmica a mejorado después de la reforma y que la política regulatoria ha tenido un efecto positivo en la eficiencia productiva.

Burocracias em ação: múltiplos atores, estratégias e conflitos na regulação federal de agrotóxicos

Esta tese busca analisar a atuação de burocracias na implementação de políticas públicas em um ambiente de múltiplios principals, stakeholders e agentes, por meio de um estudo de caso sobre a regulação federal de agrotóxicos, atribuída a três órgãos distintos – MAPA, ANVISA e IBAMA. O referencial teórico foi construído a partir das teorias de controle político da burocracia, teorias de fontes do poder burocrático e da literatura sobre implementação de políticas públicas. O formato da legislação e o nível de complexidade da política dão aos órgãos atribuições exclusivas e inúmeros espaços de autonomia, ao mesmo tempo em que lhes obriga a decidir de forma consensuada. As burocracias adotam diversas estratégias para minimizar a assimetria de informação e o risco moral por parte do setor regulado. Os principals políticos se valem de diversos instrumentos para impor suas preferências, mas o fazem de forma superficial ou esporádica. A baixa efetividade desta influência é explicada mais pelas limitações dos principals do que pela resistência dos agentes. Poder Judiciário e Ministério Público podem ser importantes parceiros ou pontos de veto à ação regulatória dos órgãos. O estilo de liderança dos gestores e a visão sobre qual deve ser o papel da burocracia em uma política regulatória explicam as diferenças observadas nos órgãos no tocante à busca de alianças e à ação estratégica perante os demais atores.

Punição, recompensa, persuasão e ajuda : estratégias regulatórias a partir do caso Nota Fiscal Paulista

Em 2007, o governo de São Paulo criou uma política regulatória chamada “Programa de Estímulo à Cidadania Fiscal” e apelidada de “Nota Fiscal Paulista”. Este programa busca estimular os consumidores a solicitarem os documentos fiscais nas compras que realizaram no varejo e a fazer com que contribuintes varejistas emitam o devido documento fiscal quando solicitado. Para atingir seus objetivos, o programa usa um complexo sistema de sanções premiais e de sanções punitivas - dentre outras estratégias - e envolve diferentes atores sociais, como contribuintes, consumidores e organizações da sociedade civil. Utilizando o método do estudo de caso, o presente trabalho busca descrever e analisar o programa Nota Fiscal Paulista, respondendo três principais questões: (i) Como funciona o programa Nota Fiscal Paulista? (ii) Como o programa Nota Fiscal Paulista foi criado? (iii) Quais são as estratégias regulatórias que ele utiliza para atingir seus objetivos e como elas podem ser organizadas? Coletando informações e argumentos desenvolvidos em cada uma dessas respostas, o trabalho busca discutir empiricamente a maneira pela qual as diferentes estratégias regulatórias foram utilizadas para a criação de uma política regulatória contemporânea, bem como destacar alguns de seus principais elementos e conceitos.